BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2913198 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00262
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT THE CONCURRENT PROCEDURE OF A TOTAL VAGINAL HYSTERECTOMY WITH ANTERIOR AND POSTERIOR REPAIR DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON 09/26/2008 DUE TO CHRONIC PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT UTEROVAGINAL PROLAPSE, RECTOCELE, CYSTOCELE, ENTEROCELE, GENUINE STRESS URINARY INCONTINENCE WITH URETHRAL HYPERMOBILITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A VAGINAL UTEROSACRAL LIGAMENT COLPOPEXY AND SUBURETHRAL SLING DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20867 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3029809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention